Eversense E3 Sensor Kit – Provider Purchase FG-7202-00-301Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00817491022974), received between Jul 5, 2022 and Jan 4, 2026 — classified as 47 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Failure to Sense” (26 reports).

1 other recall cover devices cleared under the same FDA submission (P160048); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2026Material Separation

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A BROKEN SENSOR DURING THE REMOVAL PROCEDURE WAS REPORTED ON (B)(6) 2025. ACCORDING TO THE HEALTH CARE PROVIDER (HCP), THE SENSOR FRACTURED INTO TWO PIECES DURING REMOVAL. THE SENSOR HAD BEEN IMPLANTED IN THE LEFT ARM, AND THE CLAMP PROVIDED IN THE VYGON REMOVAL KIT WAS USED DURING THE PROCEDURE. THE USER WAS CONTACTED BUT WAS UNRESPONSIVE. ALL FRAGMENTS OF THE SENSOR WERE SUCCESSFULLY REMOVED AND RETAINED FOR RETURN, AND A RETURN MATERIAL AUTHORIZATION (RMA) WAS CREATED FOR FURTHER INVESTIGATION. THE USER IS NOT CURRENTLY USING THE SYSTEM AS THE SENSOR HAD REACHED END OF LIFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23953781 ↗
• MalfunctionOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED OF HOSPITALIZATION DUE TO LEGIONNAIRES DISEASE.THE INCIDENT IS NOT RELATED TO EVERSENSE SYSTEM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23319920 ↗
• MalfunctionOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHEREAS PER MEDICAL RECORDS, THE PATIENT WAS ADMITTED AFTER PRESENTING WITH DIZZINESS, RIGHT UPPER EXTREMITY TREMOR, AND BLURRED VISION. A CODE STROKE WAS INITIATED IN THE EMERGENCY DEPARTMENT (ED), AND THE PATIENT WAS ADMITTED FOR FURTHER EVALUATION OF DIZZINESS. THE PATIENT REPORTED A BLOOD SUGAR (BS) LEVEL OF 70 MG/DL PRIOR TO ARRIVAL AND HAD CONSUMED SUGAR WATER BEFORE COMING TO THE HOSPITAL BUT CONTINUED TO EXPERIENCE DIZZINESS. ACCORDING TO THE RECORDS, STROKE PROTOCOL WAS FOLLOWED, AND A CT SCAN OF THE HEAD SHOWED NO EVIDENCE OF STROKE. A REVIEW OF THE DATA MANAGEMENT SYSTEM (DMS) CONFIRMED THAT ON THE DATE OF THE EVENT, AUGUST 11, 2025, THE USER WAS NOT USING THE SYSTEM, AND NO SENSOR GLUCOSE (SG) DATA WERE AVAILABLE. THE LAST SG VALUE RECORDED IN THE DMS WAS ON (B)(6) 2025.

  Patient problems: Blurred Vision; Dizziness

  MAUDE report 23315446 ↗
• InjurySep 18, 2025Imprecision; Imprecision

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE PATIENT ATTENDED VISIT 5. DURING THE REVIEW OF HIS DIARY, THE STUDY COORDINATOR (SC) NOTED THAT ON (B)(6) 2025, THE PATIENT REPORTED A BLOOD GLUCOSE LEVEL OF 601 MG/DL, INDICATING A HYPERGLYCEMIC EPISODE. THE PATIENT STATED THAT HE WENT TO THE EMERGENCY ROOM AND WAS STABILIZED WITH INSULIN. THE SC REQUESTED THE HOSPITAL MEDICAL RECORD FOR CONFIRMATION. THE PATIENT ALSO REPORTED THAT HE DID NOT USE THE TRANSMITTER AT THAT TIME. HE WAS DISCHARGED THE SAME DAY AND WAS NOT ADMITTED TO THE HOSPITAL.

  Patient problems: Hyperglycemia

  MAUDE report 23080912 ↗
• InjuryAug 10, 2025Difficult to Remove; Difficult to Remove

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR ON THE FIRST ATTEMPT MADE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 22768115 ↗
• InjuryAug 1, 2025Imprecision; Insufficient Device Problem Information; Imprecision; Insufficient Device Problem Information

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIC EPISODE WENT TO ER AND ADMITTED TO THE HOSPITAL.

  Patient problems: Hypoglycemia

  MAUDE report 22693122 ↗
• InjuryJul 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SENSEONICS WAS MADE AWARE OF A NON-EVERSENSE DEVICE RELATED SERIOUS ADVERSE EVENT WHERE THE PATIENT WAS HOSPITALIZED FOR ACUTRE HYPOXEMIC RESPIRATORY FAILURE. THE PATIENT WAS ADMITTED TO ICU AND WAS TREATED AND WAS TREATED FOR PNEUMONIA AND EMBOLISM WITH MEDICATIONS.

  Patient problems: Hypoxia; Pneumonia

  MAUDE report 22408142 ↗
• InjuryJun 7, 2025Difficult to Remove; Difficult to Remove

  ON 08 MAY SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED UNSUCCESSFUL REMOVAL ATTEMPT OF THE SENSOR ON (B)(6) 2025. A SECOND REMOVAL ATTEMPT WAS ALSO DONE ON (B)(6) 2025, WHICH WAS ALSO UNSUCCESSFUL. SENSOR WAS PALPABLE BEFORE THE INCISION. TRANSMITTER WASN'T USED TO LOCALIZE THE SENSOR. ULTRASOUND WAS USED TO LOCALIZE THE SENSOR.THE SENSOR WAS SUCCESSFULLY REMOVED ON THE THIRD REMOVAL ATTEMPT ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22163741 ↗
• InjuryMay 24, 2025Difficult to Remove; Difficult to Remove

  ON (B)(6) 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE HCP WAS UNABLE TO REMOVE THE SENSOR ON THE FIRST ATTEMPT MADE ON (B)(6) 2025. HOWEVER, THE SENSOR WAS SUCCESSFULLY REMOVED DURING SECOND REMOVAL ATTEMPT ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22082184 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SENSEONICS WAS MADE AWARE OF A SERIOUS ADVERSE EVENT WHERE THE PATIENT WAS HOSPITALIZED DUE TO DIABETIC KETOACEDOSIS ON (B)(6) 2023.

  Patient problems: Diarrhea; Dizziness; Elevated Ketones/ Diabetic Ketoacidosis; Vomiting

  MAUDE report 22075292 ↗
• MalfunctionApr 4, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  ON MARCH 7, 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774426 ↗
• MalfunctionMar 18, 2025Premature End-of-Life Indicator; Failure to Sense; Premature End-of-Life Indicator; Failure to Sense

  ON FEBRUARY 17, 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21636874 ↗
• InjuryMar 12, 2025Imprecision; Imprecision

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED LOSS OF CONSCIOUSNESS FOR SEVERAL SECONDS WHILE DRIVING DUE TO HYPOGLYCEMIA ON (B)(6) 2024. THE USER WAS ABLE TO PULL OVER AND TREATED BY EATING SNACKS AND DID NOT SEEK MEDICAL ATTENTION.

  Patient problems: Hypoglycemia

  MAUDE report 21590580 ↗
• InjuryMar 2, 2025Imprecision; Imprecision

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A HIGH GLUCOSE EVENT. THE FOLLOWING EXAMPLE SET WAS PROVIDED: (B)(6) 2025 - 12:00 PM - SG: 173MG/DL, BG: 300MG/DL. (B)(6) 2025 - 4:07 PM - SG: 130MG/DL, BG: 500MG/DL. AFTER DMS REVIEW, WE CONFIRMED THE FOLLOWING INFORMATION AT THE TIME OF THE EVENT: (B)(6) 2025 - 12:30 PM - SG: 192 MG/DL, BG: 332MG/DL. (B)(6) 2025 - 4:07 PM - SG: 130MG/DL, BG: 500MG/DL WE ARE UNABLE TO CONFIRM THIS EXAMPLE AS THERE IS A GLUCOSE GAP ON DMS AT THE TIME OF THE EVENT. AFTER DMS REVIEW, WE CONFIRMED THAT THE USER DIDN'T RECEIVE A HIGH GLUCOSE ALERT AT THE TIME OF THE EVENT BECAUSE THE SG NEVER WENT ABOVE THE ALERT LEVEL.THE USER DIDN'T SEEK MEDICAL TREATMENT AND RESOLVED THE EVENT BY ADMINISTERING INSULIN HERSELF.THE USER'S HCP ISN'T AWARE OF THE EVENT AND WAS ADVISED TO FOLLOW UP WITH THE HCP FOR FURTHER MEDICAL GUIDANCE.

  Patient problems: Hyperglycemia

  MAUDE report 21501330 ↗
• InjuryMar 2, 2025Imprecision; Imprecision

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A LOW GLUCOSE EVENT. THE FOLLOWING EXAMPLE SET WAS PROVIDED: (B)(6) 2025 (EXACT TIME NOT RECALLED BY USER). USER ESTIMATED THEIR BG AT 15 MG/DL DURING THE EVENT. WE ARE UNABLE TO CONFIRM THE DETAILS IN DMS BECAUSE THE USER DOES NOT RECALL THE EXACT TIME OF THE EVENT OR THE SENSOR READING (SG) ASSOCIATED WITH THE LOW GLUCOSE EVENT.THE USER DIDN'T SEEK FOR MEDICAL TREATMENT AND RESOLVED THE EVENT BY CONSUMING FOOD.THE USER'S HCP ISN'T AWARE OF THE EVENT, AND USER WAS ADVISED TO FOLLOW UP WITH THE HCP FOR FURTHER MEDICAL GUIDANCE.

  Patient problems: Hypoglycemia

  MAUDE report 21501310 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 21 JAN 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED OF BEING HOSPITALIZED FOR BEING SICK AND LOST CONSCIOUSNESS AND HAS NO RECOLLECTION OF THE TIME OF THE EVENT AND PER USER'S DAUGHTERS CONFIRMATION THAT THE USER WAS DIAGNOSED WITH MRSA(METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS). THE USER RECEIVED A SURGICAL PROCEDURE AS TREATMENT AT THE HOSPITAL.THE USER WAS PRESCRIBED WITH MEDICATION.

  Patient problems: Skin Infection

  MAUDE report 21426815 ↗
• InjuryDec 26, 2024Difficult to Remove; Difficult to Remove

  ON 26 NOVEMBER 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR ON THE FIRST ATTEMPT MADE ON (B)(6) 2024.

  Patient problems: Discomfort

  MAUDE report 21021283 ↗
• InjuryDec 14, 2024Material Separation; Material Separation

  ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE SENSOR BROKE INTO TWO PIECES DURING THE REMOVAL PROCEDURE.ALL THE PIECES OF THE BROKEN SENSOR WERE SUCCESSFULLY REMOVED BY THE HCP.

  Patient problems: Discomfort

  MAUDE report 20934350 ↗
• InjuryDec 12, 2024Material Separation; Material Separation

  ON 13 NOV 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE PATIENT REPORTED THAT THE SENSOR BROKE DURING REMOVAL PROCEDURE. THE EVENT HAPPENED ON (B)(6) 2024 AT APPROXIMATELY 3:00 PM. THE HCP ATTEMPTED TO REMOVE THE SENSOR WITH THE CLAMPS PROVIDED IN THE CUSTOM VYGON PROCEDURE KIT, AND THE DISTAL TIP OF THE SENSOR BROKE OFF. THE SENSOR HAD BEEN IMPLANTED IN THE UPPER ARM. ALL THE PIECES OF THE BROKEN SENSOR WERE SUCCESSFULLY REMOVED.

  Patient problems: Discomfort

  MAUDE report 20917896 ↗
• MalfunctionDec 4, 2024Failure to Sense; Failure to Sense

  ON NOVEMBER 4, 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20845999 ↗
• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE PATIENT HAS A LUMP THAT WAS DEVELOPED UNDER THE SENSOR AND WAS PUSHING THE SENSOR UP.THE SENSOR WAS SUCCESSFULLY REMOVED.PATIENT HAS CHRONIC LYMPHOCYTIC LEUKEMIA (CLL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20808414 ↗
• InjuryNov 26, 2024Difficult to Remove; Difficult to Remove

  ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF INCIDENT WHERE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR ON THE FIRST ATTEMPT MADE.THE SENSOR WAS INSERTED ON (B)(6) 2024.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20780436 ↗
• MalfunctionNov 17, 2024Connection Problem; Connection Problem

  ON 18 OCTOBER 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER COULDN'T GET PLACEMENT GUIDE TO SHOW GOOD SIGNAL AND ONLY GETS LOW TO NO SIGNAL.THE SENSOR WAS INSERTED ON (B)(6) 2024.A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED FOR THE RETURN OF THE DEVICE FOR FURTHER INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20702889 ↗
• InjuryNov 10, 2024Connection Problem; Connection Problem

  ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER WAS ONLY ABLE TO FIND LOW OR NO SIGNAL AND CAN'T PALPATE THE SENSOR.THE USER ATTEMPTED THE PLACEMENT TEST SEVERAL TIMES, BUT MOST OF THE TIME THEY CAN ONLY FIND "NO SIGNAL".THE USER IS BEING ADVISED TO CONTACT THE HCP TO DISCUSS NEXT STEPS, SUCH AS REMOVAL AND REPLACEMENT OF THE SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649277 ↗
• InjuryNov 9, 2024Communication or Transmission Problem; Connection Problem; Communication or Transmission Problem; Connection Problem

  ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT EVENT WHERE USER HAD TWO INSERTIONS IN THE SAME DAY.AS PER CASE NOTES, THE FIRST SENSOR WAS NOT ABLE TO ACHIVE EXCELLENT SIGNAL, SO THE HCP DECIDED TO INSERT A SECOND SENSOR SN (B)(6) IN A DIFFERENT ARM.THE SENSOR SN (B)(6) WITH LOW SIGNAL WILL BE REMOVED ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20648522 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160048. One submission often covers many models, so check the product and lot details in each record.

• Z-0251-2020 · Sep 18, 2019 · Terminated
  Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor